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Four Insect-borne Infectious Diseases Pathogens Multiple Fluorescence PCR probe kit
Intended use:
This product is used for in vitro qualitative detection of Malaria/Borrelia burgdorferi/Zika/Dengue virus nucleic acid in human serum samples. The test results are for clinical reference only, it cannot be used alone as the basis for the diagnosis or exclusion of cases.
Test Principle:
The kit adopt TaqMan fluorescent probe method. For the highly conserved and specific region of Malaria/Borrelia burgdorferi /Zika/Dengue, the primer probes, together with RT-PCR reaction solution for fluorescent detection are designed and labeled with different fluorescent groups. On the fluorescence quantitative PCR instrument, the real-time fluorescence quantitative PCR detection technology is used to realize the rapid detection of Malaria/Borrelia burgdorferi/Zika /Dengue through the change of fluorescent signal. The detection system contains positive internal control, used to monitor whether the nucleic acid extraction process is normal.
Product components:
1 BIK-QL-H009:
| No. | Components | Amount |
| 1 | PCR Enzyme Mix (Lyophilized) | 96 tests/bottle |
| 2 | Primer-Probe Mix 1( Malaria ) | 50 μL/vial |
| 3 | Primer-Probe Mix 2(Borrelia burgdorferi / Zika / Dengue) | 50 μL/vial |
| 4 | Enzyme Mix Buffer (5×) | 400 μL/vial |
| 5 | Positive Control | 100 μL/tube |
| 6 | Negative Control | 100 μL/tube |
| 7 | RNase-free water | 1mL/tube |
| 8 | Paraffin oil | 1.5mL/tube*2 |
2 BIK-QL-H009S:
| No. | Components | Amount |
| 1 | 1 (Malaria Mix (Lyophilized)) | 24 tests/kit |
| 2 | 2 (Borrelia burgdorferi/ Zika / Dengue Mix (Lyophilized)) | 24 tests/kit |
| 3 | Positive Control | 100 μL/tube |
| 4 | Negative Control | 100 μL/tube |
| 5 | RNase-free water | 1mL/tube |
| 6 | Paraffin oil | 1.5mL/tube |
Note: Do not mix the components from different batches for detection. The Positive Control of Malaria/Borrelia burgdorferi/Zika/Dengue and internal control were constructed artificially, and they were not infectious.
Compatible instruments:
The diagnostic kit is applicable to PCR instrument with multi-color fluorescence channel FAM , VIC/HEX, ROX and CY5 including Quant Studio5 (ABI), Micgene 244/244 IVD(BIO-KEY).
Reaction Mix Preparation:
Ⅰ. Malaria reaction mix:
| 1×volume required | |
| Resuspended master mix | 14 μL |
| Primer-Probe Mix 1 | 1 μL |
| Total volume | 15 μL |
Ⅱ. Borrelia burgdorferi / Zika and Dengue reaction mix:
| 1×volume required | |
| Resuspended master mix | 14 μL |
| Primer-Probe Mix 2 | 1 μL |
| Total volume | 15 μL |
※Multiply the numbers according to the number of tests.
PCR amplification condition:
| Step | Cycle | Temperature | Time |
| 1 | 1 | 50℃ | 10 min |
| 2 | 1 | 94℃ | 3 min |
|
3 |
40 | 94℃ | 10 s |
| 60℃ | 30 s(Collection of fluorescence) |
Interpretation of test results:
(1)Malaria reaction:
| FAM (Malaria) | CY5 (IC) | Interpretation test results | |
| 1 | - | - | Result invalid ,test again |
| 2 | + | +/- | Malaria(+) |
| 3 | - | + | Negative(-) |
(2)Borrelia burgdorferi/Zika/Denguee reaction:
| FAM (Borrelia burgdorferi) | VIC/HEX (Zika) | ROX (Dengue) | CY5 (IC) | Interpretation test results | |
| 1 | - | - | - | - | Result invalid, test again |
| 2 | + | - | - | +/- | Borrelia burgdorferi(+) |
| 3 | - | + | - | +/- | Zika(+) |
| 4 | - | - | + | +/- | Dengue(+) |
| 5 | + | + | - | +/- | Borrelia burgdorferi,Zika(+) |
| 6 | + | - | + | +/- | Borrelia burgdorferi, Dengue(+) |
| 7 | - | + | + | +/- | Zika, Dengue(+) |
| Borrelia | |||||
| burgdorferi, | |||||
| 8 | + | + | + | +/- | Zika, |
| Dengue(+) | |||||
| 9 | - | - | - | + | Negative(-) |
NOTE: ‘+ ’ is positive, ‘- ’ is negative.
Operation details please check from IFU